CONSENT TO PARTICIPATE IN NEUROIMAGING RESEARCH:
Your Project Title
Please consider this information carefully before deciding whether to participate in this research.
Purpose of the research:
The purpose of this study is to explore how specific regions in the brain are involved in
cognition. The study will use Magnetic Resonance Imaging (MRI) to create images of your
brain.
What you will do in this research:
Your participation in this study consists of lying on a table and having your body slid into a large
horizontal tube. You will be asked to lie as still as possible during this time. Foam cushions will
be used to help keep your head still. To reduce the noise of the scanner, you will be fitted with
earplugs or headphones.
During the first part of the scan, pictures will be taken of the shape of your brain. Next,
additional images will be obtained using the high-speed function of the scanner. You will be
asked to either view words, photos, or animated scenes that look like video games, and to make
decisions about these items. For certain periods you will be asked to simply rest. You will make
your decisions by pressing a key. The whole scanning session will last up to 2 hours, with an
extra 30 minutes before and after the scan for preparation and debriefing. At the end of the
experiment, you will be given a detailed explanation of the purpose of the study.
The results from your study may be pooled with those of other similar studies and shared among
researchers or used for teaching purposes. For example, a researcher at another institution may
wish to reexamine the results of this study. When results are shared, they are identified only by a
code number. At no time will any identifying information such as your name be shared. Please
choose not to participate in this study if you are uncomfortable with your coded data being
shared.
In some cases, we may be interested in re-contacting you for additional information or to
participate in a follow-up experiment. If we do, your participation is completely optional and you
would be compensated appropriately for your time. If you would prefer that we refrain from recontacting you, please initial below to indicate this.
Initial if you would prefer NOT to be re-contacted following this study: _________
Time required:
This study will last approximately 2-3 hours.
Risks:
MRI uses large magnet fields. There are no known or foreseeable risks or side effects associated
with scanning procedures except for those people who have electrically, magnetically or
mechanically activated implants, or metal in or on their bodies. The 3 tesla MRI system is
approved and operated by guidelines set forth by the U.S Food and Drug Administration.
Although the vast majority of data suggests that it is perfectly safe for embryos or fetuses to be
scanned, there is still much that remains unknown. For this reason, we believe that it is safer to
err on the side of caution and not allow anyone who suspects they might be pregnant to
participate in MRI scanning. If you are pregnant of you feel that there is any chance that you
may be pregnant, you should not participate in this study at this time. You do not need to tell us
why you have chosen not to participate.
Because of the effects of medication and mental illness on the brain, you will be asked a series of
questions about whether you are presently taking or have ever taken medication for depression,
anxiety, and other forms of mental condition (e.g., schizophrenia). You will be asked about your
history of neurological and psychiatric illness. If you have previously taken such medications or
are currently taking any you should not participate in this study. If you feel uncomfortable in
discussing such information, you should not participate. You do not need to tell us why you have
chosen not to participate.
A MRI scan is not uncomfortable but if you are prone to claustrophobia (fear of enclosed spaces)
you should notify the researcher in charge of the scan. You can expect to hear a loud knocking
sound during the imaging. Earplugs will be provided to help dim the sound. It is important that
you remain as still as possible during the study. The foam pillows are reasonably comfortable,
and are designed to keep your head still and in a relaxed position. If any of the procedures are
uncomfortable, you should notify the researcher in charge of the scan. You will be given a signal
button to indicate at any time that you wish to stop.
This project is for research purposes only and is not directed toward, nor designed for, clinical
diagnosis, and the scans performed in this study are not optimized to find abnormalities. You
should not expect that your images will be looked at individually or viewed in a way that could
detect an abnormality. We will not be able to provide you the images of your brain, nor will we
be able to provide your doctor with the images. If you are participating in this study to obtain a
clinical diagnosis or images that could be used for clinical diagnosis, you should not participate.
On occasion, a member of the research team may notice a finding on a scan that seems abnormal.
If this occurs the principal investigator or a designate may tell you about the observation. The
principal investigator may consult a physician affiliated with Harvard for advice. Being told
about a finding may cause anxiety as well as suggest the need for additional tests and financial
costs. The decision as to whether to proceed with further examination or treatment would remain
entirely yours.
Benefits:
At the end of the study, we will provide a thorough explanation of the study and of our
hypotheses. We will describe the potential implications of the results of the study both if our
hypotheses are supported and if they are disconfirmed. If you wish, you can send an email
message to Professor PI’s name here (PI’s email address) and we will send you a copy of any
manuscripts based on the research (or summaries of our results).
Compensation:
You will be paid $25 per hour for your participation in this study plus $5.00 for transportation, or
free parking if you drive. These payments will be made by check through the mail.
Confidentiality:
Your participation in this study will remain confidential, and your identity will not be stored with
your data. Your responses will be assigned a code number, and the list connecting your name
with this number will be kept in a locked room. When data are shared, your name will never be
shared.
Participation and withdrawal:
Your participation in this study is completely voluntary, and you may withdraw at any time
without penalty. You will receive payment for the MRI session even if you withdraw early. You
may withdraw by informing the experimenter that you no longer wish to participate (no
questions will be asked).
Contact:
If you have questions about this research, please contact Dr. PI’s name (PI’s address; PI’s phone;
PI’s email).
Whom to contact about your rights in this research, for questions, concerns, suggestions, or
complaints that are not being addressed by the researcher, or research-related harm:
Jane Calhoun, Harvard University Committee on the Use of Human Subjects in Research, 50
Church St., 5th floor, Cambridge, MA 02138. Phone: 617-495-5459. E-mail:
jcalhoun@fas.harvard.edu
If you are injured during the course of the study and as a direct result of this study, you should
contact the investigator at the number provided. Although compensation is not available,
Harvard will assist you in obtaining medical treatment, including first aid, emergency treatment,
and follow-up care as needed. Your insurance carrier should be billed for the cost of such
treatment. If your insurance carrier denies coverage, Harvard is under no obligation to pay for
the treatment but may do so in its sole discretion. By providing financial or other assistance,
neither Harvard nor the researchers are stating that they are legally responsible for the injury.
Further information regarding compensation for injured research subjects may be obtained from
Jane Calhoun, Research Officer for the Committee at the above number.
Agreement:
The nature and purpose of this research have been sufficiently explained and I agree to
participate in this study. I understand that I am free to withdraw at any time without
incurring any penalty.
Signature: _____________________________________
Date: __________________
Name (print): ________________________________________________
1/9/09